E-4 Electrical Safety Inspection
LIMITS
For BF applied parts:
100μA in Normal Condition.
500μA in Single Fault Condition.
E.8 Mains on Applied Part Leakage
The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage using a
limiting resistance, to selected applied part terminals. Current measurements are then taken between
the selected applied part and earth. Measurements are taken with the test voltage (110% of mains) on
applied parts in the normal and reverse polarity conditions.
The following outlet conditions apply when performing the Mains on Applied Part test.
Normal Polarity;
Reversed Polarity.
LIMITS
For BF applied parts: 5000 μA.
E.9 Patient Auxiliary Current
Patient Auxiliary currents are measured between any selected Applied Part connector and the
remaining Applied Part connectors. All measurements may have a true RMS response.
The following outlet conditions apply when performing the Patient Auxiliary Current test.
normal polarity (Normal Condition);
reverse polarity (Normal Condition);
normal polarity with open neutral (Single Fault Condition);
reverse polarity with open neutral (Single Fault Condition);
normal polarity with open earth (Single Fault Condition);
reverse polarity with open earth (Single Fault Condition).
LIMITS
For BF applied parts,
100μA in Normal Condition.
500μA in Single Fault Condition.
Make sure the safety analyzer is authorized and complies with the requirements of IEC60601-
1.
Follow the analyzer manufacturer's instructions.